Wiki source code of AstraZeneca

Last modified by Wilton Risenhoover on 2022/07/06 01:12

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5.2	5	= Summary =
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5.2	7	* AstraZeneca is a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.
	8	* The company focus on the discovery, development and commercialisation of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.
8.4	9	* The company also has an active R&D presence in 40 other countries spanning the globe with 10,000 - employees work exclusively in R&D.
5.2	10	* Commercial teams of around 43,400 employees are active in more than 100 countries
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5.2	12	[[image:AZN0.png\|\|height="175" width="721"]]
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5.2	14	= Company Overview =
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5.2	16	AstraZeneca (LSE:AZN, NASDAQ:AZN) is a global, science-led biopharmaceutical business and its innovative medicines are used by millions of patients worldwide.{{footnote}}https://www.astrazeneca.com/our-company.html{{/footnote}}
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5.2	19	The company's business is organised to deliver its strategic priorities sustainably, supporting continued scientific innovation and commercial success. The company focus on the discovery, development and commercialisation of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. The company's Commercial teams, which comprised around 43,400 employees at the end of 2020, are active in more than 100 countries.
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5.2	22	[[image:AZN1.jpg]]
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5.2	25	== R&D Centres ==
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5.2	27	AstraZeneca is committed to its purpose of pushing the boundaries of science to deliver life changing medicines and AstraZeneca has built its business around it. AstraZeneca has three strategic R&D centres in Cambridge, UK, Gaithersburg, US, and Gothenburg, Sweden. The company also have an active R&D presence in 40 other countries spanning the globe.{{footnote}}https://www.astrazeneca.com/r-d/our-strategic-r-d-centres.html{{/footnote}}
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5.2	29	* 3 - strategic R&D centres in the UK, US and Sweden
	30	* 40 - active R&D presence in other countries spanning the globe
	31	* 10,000 - employees work exclusively in R&D
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	33	The company's pipeline forms a robust portfolio of investigational therapies in varied stages of clinical development.
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	35	* 175projects in its pipeline
	36	* 17new molecular entities in its late-stage pipeline
	37	* 1new molecular entity approval
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6.2	39	[[image:AZN4.png\|\|alt="AZN2.png"]]
5.2	40
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	42	=== Cambridge ===
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	44	Officially unveiled in November 2021, The Discovery Centre (DISC) at the Cambridge Biomedical Campus (CBC) is its largest R&D facility in the UK. More than 2,000 people will work together across its therapy areas and drug discovery and development.
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	47	The physical proximity of The DISC to its neighbours in academia, healthcare and industry creates a porous environment where ideas and talent can be shared to drive innovation. The new state-of-the-art R&D facility will strengthen its collaborations across the city, expanding its 200 partnerships within the Cambridge ecosystem and hundreds more in the wider UK life sciences cluster
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	50	=== Gaithersburg ===
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	52	A unique, innovative and inclusive modern campus, just a short drive away from Washington, DC, its Gaithersburg facility is home to a diverse community of some 3,500 people, with the capacity to discover, develop, manufacture, and commercialise life changing medicines – all on one site.
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	55	With a team of world-renowned scientists, cutting-edge technology, and a collaborative, interactive and cross-functional scientific culture, it’s a great place to work and an exciting place to be. The company's outstanding facilities and amenities promote wellness and a positive work-life balance, helping it attract and retain the best talent, while contributing to its business’s values-led and sustainable approach to R&D.
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	58	=== Gothenburg ===
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	60	With more than 2,400 employees from 50 countries, its vibrant Gothenburg site helps support the entire life-cycle of AstraZeneca medicines, from drug discovery and clinical trials, through to global commercialisation and product maintenance. In 2017, the company launched Lab4Life, creating an open and truly shared research environment that goes beyond the usual laboratory model. By breaking down traditional lab walls, automating processes and driving state of-the-art IT, AstraZeneca is creating novel ways of working to speed up delivery of new medicines.
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	63	Looking to the future, Gothenburg has initiated the creation of a new, global cluster for health and life sciences, as part of the GoCo Health Innovation City project, which includes the Gothenburg BioVentureHub. There are currently more than 30 external companies and one academic group co-locating with AstraZeneca at the heart of the Gothenburg site. By facilitating interactions between drug, device, diagnostics and digital health companies, AstraZeneca is creating a dynamic, creative and fertile environment for helping unlock the power of what science can do.
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8.1	66	[[image:AZN5.jpg\|\|alt="AZN2.png"]]
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6.2	68
5.2	69	= Therapy Area =
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	71	== Oncology ==
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6.2	73	AstraZeneca has a bold ambition to provide cures for cancer in every form. AstraZeneca is following the science to understand cancer and all its complexities to discover, develop and deliver life-changing treatments and increase the potential to save the lives of people around the world.{{footnote}}https://www.astrazeneca.com/our-therapy-areas/oncology.html{{/footnote}}
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	76	The company's Oncology strategy is built with one goal in mind – to push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. The company's broad pipeline of next-generation medicines, together with its focus on excellence in execution, are aimed at expanding treatment options and improving outcomes for patients with solid tumours and haematological cancers.
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	78	The company focus on four strategic priorities:
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6.2	80	* Pioneering research across six scientific platforms: Tumour drivers and resistance; Immuno-oncology; DNA damage response, Antibody drug conjugates, Epigenetics and Cell therapies
	81	* Advancing innovative clinical strategies to treat early stages of disease and relapsed or refractory patients
	82	* Building expertise and leadership in the most prevalent and highest mortality rate tumour types
	83	* Delivering across its global footprint
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6.2	85	key disease areas
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	87	The company's focus is on some of the most hostile and hard-to-treat cancers. By understanding the complexities of cancer, the company hope to achieve life-changing benefits for patients.
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6.2	90	== BioPharmaceuticals ==
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6.2	92	Through its work in BioPharmaceuticals, the company want to transform healthcare, change the lives of billions of people for the better and address some of the biggest healthcare challenges facing humankind. There remains a huge unmet need in treating people with chronic diseases. The company's ambition is to stop the progress of these often degenerative, debilitating, and life-threatening conditions, achieve remission, and one day cure them.{{footnote}}https://www.astrazeneca.com/our-therapy-areas/biopharmaceuticals.html{{/footnote}}
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	95	BioPharmaceuticals is responsible for its key therapy areas of Cardiovascular, Renal & Metabolism and Respiratory & Immunology.
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	98	The company's BioPharmaceuticals R&D and Business Unit are unified in its approach to deliver life-changing medicines for people living with the most common chronic diseases.
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	101	The company will achieve its ambition of transforming healthcare through its talented teams and partners using scientific, medical and commercial innovation.
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6.2	104	BioPharmaceuticals Business Unit
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5.2	106	The company's commercial teams are transforming how the company bring products to market; engage with patients, healthcare providers and health systems; and deliver healthcare solutions that support them.
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6.2	109	== Cardiovascular, Renal and Metabolism ==
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6.2	111	The company aim to save the lives of people who suffer from cardiovascular disease, heart failure, chronic kidney disease and diabetes, by advancing CVRM solutions and addressing shared risk factors between these distinct but interrelated disease areas{{footnote}}https://www.astrazeneca.com/our-therapy-areas/cardiovascular-renal-and-metabolism.html{{/footnote}}
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	114	Cardiovascular, Renal & Metabolism (CVRM) diseases are the leading causes of death across the globe, killing more than 20 million people each year.
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	116	AstraZeneca is committed to advancing the science and treatment of four interrelated conditions – cardiovascular disease, heart failure, metabolic and renal diseases. Science continues to identify the underlying links between the heart, kidney and pancreas, and how the interconnectivity of these organs is reflected in the relationship of the diseases that can occur. Damage to any one of these organs can cause the other organs to fail. Unfortunately, in many instances, these conditions are either under-diagnosed or not addressed early enough to avoid life-threatening complications. AstraZeneca is focused on delivering targeted treatment options that address the root cause of these diseases and help to manage complications.
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8.1	119	== Respiratory & Immunology ==
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8.1	121	Building on a 50-year heritage in respiratory care, its ambition is to transform the treatment of asthma and chronic obstructive pulmonary disease (COPD) by driving earlier, biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death.{{footnote}}https://www.astrazeneca.com/our-therapy-areas/respiratory-and-immunology.html{{/footnote}}
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5.2	124	Underpinning chronic lung diseases is an altered immune system. AstraZeneca is following the science of common pathways and underlying disease drivers from respiratory disease into immunology-driven disease areas.
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	127	The disease areas we’re targeting include rheumatology (including type 1 interferon-driven diseases such as lupus), dermatology, gastrointestinal diseases and inflammatory diseases driven by eosinophilic immune dysfunction. The company's ambition is to achieve disease modification and durable remission in these diseases for millions of patients worldwide.
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	130	More than 700 million people have asthma or COPD. Despite currently available medicines, therapeutic advances are needed to reduce morbidity and mortality. Lupus is a debilitating autoimmune condition affecting up to five million people. No new medicines have been approved in nearly a decade.
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5.2	133	339 million individuals worldwide have asthma and more than 60% of patients have uncontrolled disease. Prevalence is expected to rise.
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5.2	136	Globally, 384 million people have COPD, and it is the third leading cause of death worldwide. COPD exacerbations represent a significant burden for patients, carers and society. COPD costs are estimated to exceed $100 billion per year globally.
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5.2	139	The company's aim is to lead the science of respiratory medicine to transform the treatment of asthma and COPD by eliminating preventable asthma attacks across disease severities and removing COPD as a leading cause of death through earlier, biology-led treatment. In immunology, AstraZeneca is following the science and its expertise in key inflammatory pathways that are relevant in other immune-mediated conditions, with the ambition of achieving disease control and durable remission in areas of high unmet medical need.
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8.1	142	== Other Medicines and COVID-19 ==
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8.1	144	AstraZeneca has medicines and vaccines in other disease areas that have an important impact for patients. As such, AstraZeneca is selectively active in the areas of autoimmunity, infection & vaccines, neuroscience and gastroenterology, where the company follow an opportunity-driven approach and often work through partnerships.{{footnote}}https://www.astrazeneca.com/our-therapy-areas/other-disease-areas.html{{/footnote}}
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5.2	147	AstraZeneca is working to defeat the COVID-19 pandemic by advancing and accelerating the development of potential medicines that prevent or treat the virus.
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	149	The WHO estimates that seasonal influenza may result in nearly one billion cases of influenza and 290,000 to 650,000 deaths each year due to influenza-related respiratory diseases.
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	151	By the end of January 2021, the Johns Hopkins Disease Tracker had recorded more than 100 million confirmed cases of COVID-19 and more than two million deaths. Almost 60 million people had recovered.
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	153	The company's approach to other disease areas looks to maximise revenue of on market medicines, divest medicines, where this enhances shareholder value, and advance the novel medicine pipeline with collaborations where appropriate, whilst preserving a financial stake in the most promising assets.
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8.1	156	COVID-19 Vaccine AstraZeneca
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	158	In April, the company announced an agreement with the University of Oxford to develop, manufacture and supply a potential vaccine to prevent COVID-19. Both parties shared a commitment to delivering it in a broad, equitable and timely way, and at no profit during the pandemic.
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8.1	164	= Business Overview =
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8.1	167	The company's Commercial teams, which comprised around 43,400 employees at the end of 2020, are active in more than 100 countries. In most countries, the company sell its medicines through wholly owned local marketing companies. The company also sell through distributors and local representative offices. The company market its products largely to primary care and specialty care physicians.{{footnote}}https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf{{/footnote}}
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	170	Total Revenue, comprising Product Sales and Collaboration Revenue, increased by 9% in 2020 (10% at CER) to $26,617 million. Product Sales grew by 10% (11% at CER) to $25,890 million, driven primarily by the performances of the new medicines across Oncology and BioPharmaceuticals, including Tagrisso and Farxiga.
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5.2	173	Total Revenue included $2m of COVID-19 Vaccine AstraZeneca Product Sales within Other Medicines; from the first quarter of 2021 AstraZeneca intends to report the COVID-19 Vaccine AstraZeneca performance separately
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5.2	176	The ongoing COVID-19 pandemic had a significant impact on every aspect of life in 2020, AstraZeneca. The largest direct impacts of COVID-19 on the its portfolio of medicines included reduced sales of Pulmicort in China on fewer nebulisation-centre visits and reduced elective surgery, and less use globally of infused and injectable medicines, such as Imfinzi and Fasenra.
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5.2	179	There was also a decline in the number of hospital admissions around the world for the treatment of heart attacks and lower levels of elective percutaneous coronary intervention, adversely impacting sales of Brilinta.
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5.2	182	Some medicines, however, may benefit from shifts in patient care and behaviours, including oral medicines such as Calquence, which saw an element of benefit from the substitution from infused-chemotherapy regimens.
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5.2	185	Additional investment in new medicines continued to fuel its growing Oncology and BioPharmaceuticals therapy areas. Tagrisso’s future was enhanced with its first regulatory approval in early, potentially-curable lung cancer and further national reimbursement in China in advanced disease. Farxiga expanded its potential beyond diabetes, while tezepelumab promised hope for patients suffering from severe asthma.
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8.1	188	US
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5.2	190	As the sixteenth largest prescription-based pharmaceutical company in the US, AstraZeneca has a 2.7% market share of US pharmaceuticals by sales value. In 2020, Product Sales in the US increased by 12% to $8,638 million (2019: $7,747 million).
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5.2	193	The US healthcare system is complex with multiple payers and intermediaries exerting pressure on patient access to branded medicines through regulatory rebates in government programmes and voluntary rebates paid to managed care organisations and pharmacy benefit managers for commercially insured patients, including Medicare Part D patients. In the Medicare Part D programme, branded pharmaceutical manufacturers are also statutorily required to pay a percentage of the patient’s out-ofpocket costs during the ‘coverage gap’ portion of their benefit design.
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5.2	196	In 2020, the overall measurable reduction in its profit before tax for the year due to discounts on branded pharmaceuticals in the Medicare Part D Coverage Gap and an industry-wide HealthCare Reform Fee was $590 million (2019: $547 million; 2018: $432 million; 2017: $119 million)
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5.2	199	In the US, there is significant pricing pressure driven by payer consolidation, restrictive reimbursement policies and cost control tools, such as exclusionary formularies and price protection clauses. Many formularies, employ ‘generic first’ strategies and/or require physicians to obtain prior approval for the use of a branded medicine where a generic alternative exists. These mechanisms can be used to limit use of branded products and pressure manufacturers to reduce net prices. In 2020, 85.3% of prescriptions dispensed in the US were generic (2019: 84.8%). In addition, patients continue to see changes in the design of their health plan benefits and may experience increases, in both premiums and out-of-pocket payments for branded medications. There is a growing trend towards high-deductible health plans which may require patients to pay the full list price until they meet certain out-of-pocket thresholds.
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8.1	202	Europe
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5.2	204	The total European pharmaceutical market was worth $211 billion in 2020. AstraZeneca is the thirteenth largest prescription-based pharmaceutical company in Europe (see Market definitions on page 280) with a 2.0% market share of pharmaceutical sales by value.
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5.2	207	In 2020, Product Sales in Europe increased by 16% at actual rate of exchange (15% at CER) to $5,059 million (2019: $4,350 million). The company continued to launch and saw sustained performance of innovative medicines, in particular with Tagrisso, Imfinzi, Lynparza, Forxiga and Fasenra. Oncology sales in Europe grew by 36% (35% at CER), driven by increased use of Tagrisso for the treatment of patients in the 1st-line EGFR7-mutated (EGFRm) non-small cell lung cancer (NSCLC) setting, as well as continued strong levels of demand in the 2nd-line setting. Imfinzi sales reflect a growing number of reimbursements. Lynparza sales benefited from the increasing levels of reimbursement and BRCA-testing rates. Forxiga sales growth of 36% (35% at CER) was accompanied by Fasenra sales increase of 72% (70% at CER). With the increased focus on flu vaccination programmes, FluMist sales saw a significant increase of 135% (126% at CER).
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8.1	210	Japan
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5.2	212	Japan remains an attractive market for innovative pharmaceutical companies, positioned as the third largest pharmaceutical market for R&D-driven companies. In 2020, there was continued pressure on healthcare spend and, being an even year, the biennial government-induced price control measurements were in place.
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5.2	215	Total Revenue in Japan was $2,620 million, positioning AstraZeneca as the sixth largest prescription-based pharmaceutical company with a 3.5% value market share of pharmaceutical sales by value.
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5.2	218	Revenue has been kept flat versus 2019 ($2,591 million) outperforming the negative market growth despite challenges linked to COVID-19, regular biennial price cut in April, repricing for Imfinzi and Faslodex, and generic entry for Symbicort (December 2019) and Pulmicort (January 2020).
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5.2	221	Results have been driven by strong performance from Oncology brands Tagrisso, Imfinzi and Lynparza as well as Fasenra, Breztri and Forxiga.
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8.1	224	Canada
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5.2	226	Product Sales in Canada increased by 29% at actual rate of exchange (31% at CER) in 2020. This was primarily driven by strong sustained growth of its New Medicines, particularly Imfinzi, Tagrisso, Lynparza and Fasenra coupled with Symbicort sales benefiting from the regulatory approval to use the product as an anti-inflammatory reliever as-needed in mild asthma coupled with improved adherence related to COVID-19.
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5.2	229	Decline of Onglyza was accompanied by the impact of divestments, particularly Losec. There continues to be pricing pressure from both public and private payers. The company remain committed to exploring innovative value-based pricing solutions that benefit patient outcomes.
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8.1	232	Australia and New Zealand
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5.2	234	The company's sales in Australia and New Zealand increased by 8% at actual rate of exchange (10% at CER) in 2020. This was primarily due to growth in key brands such as Symbicort (which benefited from a strong LABA/ICS class growth from the impact of the bushfires earlier in the year and then COVID-19), Tagrisso, Lynparza and Forxiga. These were supplemented by strong growth in Fasenra in its first full year after reimbursement and an earlier than expected Pharmaceutical Benefits Scheme (PBS) listing of Imfinzi. The decline in older, non-patent protected brands such as Crestor and Nexium continued but were more than offset by the growth brands. Australia remains a predominantly HTA-reimbursed market with products aiming to be reimbursed needing to show a clear level of cost effectiveness and benefit to patients versus existing standard of care. Within this context, the Group’s pipeline of new assets and indications provide good opportunities for continued future growth.
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8.1	237	Emerging Markets
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8.5	239	Emerging Markets, as defined in Market definitions on page 280, comprise various countries with dynamic, growing economies. As outlined in Healthcare in a changing world from these countries represent a major growth opportunity for the pharmaceutical industry due to high unmet medical need and sound economic fundamentals. Emerging Markets are not immune, however, to economic downturn. Market volatility is higher than in Established Markets, and various political and economic challenges exist. These include regulatory and government interventions. In selected markets, governments are encouraging local manufacturing and investment by offering more favourable market access conditions and pricing is increasingly controlled by payers through price referencing regulations in addition to cost effectiveness and cost minimisation approaches.
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5.2	242	Growth drivers for Emerging Markets include new medicines across its Oncology, CVRM and Respiratory & Immunology portfolios. To educate physicians about its broad portfolio, AstraZeneca is selectively investing in sales capabilities where opportunities from unmet medical need exist. AstraZeneca is also expanding its reach through multi-channel marketing and external partnerships.
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8.5	245	With revenues of $8,711 million (2019: $8,171 million), AstraZeneca was the fourth largest multinational pharmaceutical company, as measured by prescription sales, and the second fastest-growing top 10 multinational pharmaceutical company in Emerging Markets in 2020. Despite the impact of COVID-19 across all geographies the company saw growth across all major areas including Latin America at 12% (18% at CER), Russia & Eurasia at 26% (39% at CER), Middle East & Africa down 4% (up 1% at CER) and Asia Area at 5% (7% at CER).
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8.1	248	[[image:AZN2.png]]
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8.5	250	{{putFootnotes/}}
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8.1	252	= Financial Highlights =
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8.1	254	== Q3 2021 results ==
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8.1	256	12 November 2021; In the year to date, AstraZeneca delivered double-digit revenue growth from its Oncology, CVRM1 and R&I2 medicines, and established its Rare Disease capability with the acquisition of Alexion Pharmaceuticals Inc. (Alexion). Rare disease is a high-growth area with rapid innovation and significant unmet medical need. Since June, AstraZeneca has made significant progress with its late-stage pipeline, reporting eight positive Phase III trial results and the approval of Saphnelo (anifrolumab) in the US for the treatment of systemic lupus erythematosus, and Ultomiris in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria. Enhertu received a Breakthrough Therapy Designation from the US FDA3 following ground-breaking results from the DESTINY-Breast03 trial. The Company also announced positive results for Lynparza in prostate cancer, Imfinzi plus tremelimumab in liver cancer, Imfinzi in biliary tract cancer, PT027 in asthma, ALXN1840 in Wilson disease, and AZD7442 in COVID-19 prophylaxis and treatment.{{footnote}}https://www.astrazeneca.com/content/dam/az/PDF/2021/q3/Year-to-date_and_Q3_2021_results_announcement.pdf{{/footnote}}
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8.1	258	* Total Revenue in the year to date, including Alexion from 21 July 2021, was $25,406m, representing growth of 32% (28% at CER). Total Revenue in the third quarter increased by 50% (48% at CER) to $9,866m
	259	* Excluding the pandemic COVID-19 vaccine, Total Revenue increased 21% (17% at CER) in the year to date to $23,187m, and by 34% (32% at CER) in the quarter to $8,816m
	260	* Eight positive Phase III results since June, with potential to change standard of care in several diseases
	261	* Alexion integration progressing well, creating new opportunities in rare diseases
	262	* Operating Expenses in the quarter reflected the addition of Alexion, as well increased R&D expenses across multiple programs, investment in its COVID-19 medicines, and increased SG&A from pre-launch activities following successful pipeline delivery
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8.1	264	Pascal Soriot, Chief Executive Officer, commented:
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	266	AstraZeneca’s scientific leadership continues to provide strong revenue growth and exceptional pipeline delivery, with eight positive late-stage readouts across seven medicines since June, including its long acting antibody combination showing promise in both prevention and treatment of COVID-19. The addition of Alexion furthers its commitment to bring transformative therapies to patients around the world, and I am proud of its colleagues’ ongoing dedication and focus.
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	268	The company's broad portfolio of medicines and diversified geographic exposure provides a robust platform for long-term sustainable growth. Following accelerated investment in upcoming launches after positive data flow, the company expect a solid finish to the year and its earnings guidance is unchanged.”
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5.2	271	Key elements of Total Revenue performance in the year-to-date included: -
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8.1	273	* An increase in Product Sales of 33% (29% at CER) to $25,043m
	274	* The first contribution from Rare Disease, which generated $1,311m of revenue in the period following completion of the Alexion acquisition on 21 July 2021
	275	* Oncology growth of 19% (16% at CER) to $9,744m, CVRM growth of 14% (10% at CER) to $6,028m and R&I growth of 16% (12% at CER) to $4,456m
	276	* An increase in Emerging Markets revenue of 33% (28% at CER) to $8,618m. In China, revenue increased 17% (8% CER) to $4,699m in the year to date and by 10% (2% CER) in the quarter. China revenues in the year to date were impacted by pricing pressure associated with NRDL11 and VBP12 programmes.
	277	* Tagrisso’s sequential quarterly performance in China was impacted by inventory phasing and stock compensation relating to NRDL changes in March. In future periods, volume growth from increased patient access is expected to compensate for the lower NRDL price
	278	* Revenue in ex-China Emerging Markets increased 60% in the year to date to $3,919m. Excluding vaccine revenue of $1,139m, revenue in ex-China Emerging Markets increased by 13% in the year to date (14% at CER) to $2,780m and by 30% in the quarter to $1,018m, driven by Oncology medicines and Farxiga
	279	* In the US, Total Revenue increased by 29% to $8,305m and in Europe by 40% (31% at CER) to $5,178m, including pandemic COVID-19 vaccine revenue of $736m
	280	* Growth in Core EPS13 to $5.05 to $5.40, in line with prior guidance.
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8.1	282	Oncology Total Revenue of $9,744m in the year to date; an increase of 19% (16% at CER). Oncology represented 38% of overall Total Revenue (YTD 2020: 43%).
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8.1	285	BioPharmaceuticals: CVRM Total Revenue increased by 14% in the year to date (10% at CER) to $6,028m and represented 24% of Total Revenue (YTD 2020: 27%), reflecting the strong performance of Farxiga in the period.
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8.1	288	BioPharmaceuticals: Respiratory & Immunology Total Revenue, which included Ongoing Collaboration Revenue of $12m from Duaklir, Eklira and other medicines, increased by 16% in the year to date (12% at CER) to $4,456m and represented 18% of Total Revenue (YTD 2020: 20%). Due to the adverse effect of COVID-19 on Pulmicort sales in the first nine months of 2020, the year-on-year comparison was favourably impacted.
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8.1	291	Rare Disease Total Revenue recorded post-acquisition from 21 July 2021, entirely comprising Product Sales, amounted to $1,311m representing a pro rata increase of 5% (6% at CER) in Q3 2021. Pro forma pro rata growth rates on Rare Disease medicines for Q3 2021 have been calculated by comparing post-acquisition revenues from 21 July 2021 with the corresponding prior year pre-acquisition Q3 revenues previously published by Alexion, adjusted pro rata to match the post-acquisition period.
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8.1	294	Other medicines (outside the main disease areas) Total Revenue, primarily comprising Product Sales, amounted to $1,648m in the year to date, a decrease of 13% (16% at CER). This does not include revenue from the COVID-19 vaccine, which is covered in the COVID-19 commentary. Other medicines Total Revenue represented 6% of overall Total Revenue (YTD 2020: 10%).
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8.1	297	EBITDA of $5,686m in the year to date (YTD 2020: $6,027m) has been negatively impacted by the $1,044m (YTD 2020: $nil) unwind of inventory fair value uplift recognised on acquisition of Alexion. The unwind of inventory fair value is expected to depress EBITDA over approximately 18 months post-acquisition in line with revenues.
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	300	EBITDA of $1,114m in the quarter to date (Q3 2020: $1,972m) has been negatively impacted by the $1,044m (YTD 2020: $nil) unwind of inventory fair value uplift recognised on acquisition of Alexion. The unwind of inventory fair value is expected to depress EBITDA over approximately 18 months post-acquisition in line with revenues.
	301
8.1	302
5.2	303	Gross Profit Margin in the year to date declined eleven percentage points to 68.8%; Core Gross Profit Margin declined six percentage points in the year to date to 74.1% predominantly reflecting the equitable supply, at no profit to AstraZeneca, of the pandemic COVID-19 vaccine, together with an increasing impact from profitsharing arrangements (primarily Lynparza and roxadustat) and the impact of the NRDL and VBP programmes in China. These effects were partially offset by the contribution from Alexion from 21 July 2021, a higher proportion of Oncology sales, and increasing patient access in China. Reported Gross Profit Margin has also been impacted by the unwind of the fair value adjustment to Alexion inventories at the date of acquisition. The fair value uplift is expected to unwind through Reported Cost of Sales over the 18 months post-acquisition, and in Q3 2021, the impact of the fair value uplift unwind on Cost of Sales was $1,044m. Variations in gross margin performance between periods can be expected to continue.
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8.1	305
5.2	306	Reported Total Operating Expense increased in the year to date by 39% (34% at CER) to $17,591m. Core Total Operating Expense increased by 24% (20% at CER) to $13,649m and represented 54% of Total Revenue (YTD 2020: 57%).
	307
8.1	308
5.2	309	Reported R&D Expense increased in the year to date by 67% (63% at CER) to $7,152m including an impairment charge of $1,172m recognised in the quarter on an intangible asset related to the acquisition of Ardea Biosciences, Inc. in 2012, following the decision to discontinue the development of verinurad. Core R&D Expense increased in the year to date by 34% (30% at CER) to $5,591m with increases in both Reported and Core R&D Expense reflecting the Company’s continued investment in its COVID-19 vaccine and AZD7442, and other costs related to COVID-19, such as personal protective equipment and colleague COVID-19 testing across the Company. The increases also reflected the investment in several late-stage Oncology trials and the advancement of a number of Phase II clinical development programmes in BioPharmaceuticals, mainly in CVRM. In the year to date, grant income of $451m has been recognised, of which $281m has been offset against the US clinical trial costs for AZD1222 and $170m offset against costs for AZD7442.
	310
8.1	311
5.2	312	Reported EPS in the year to date declined 80% (65% at CER) to $0.33. Core EPS increased by 22% (23% at CER) to $3.59. Reported and Core EPS were adversely affected by $0.03 due to the pandemic COVID-19 vaccine.
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8.1	315	= Recent developments =
5.2	316
8.1	317	AstraZeneca and Neurimmune sign exclusive global collaboration and licence agreement to develop and commercialise NI006{{footnote}}https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/astrazeneca-and-neurimmune-sign-deal-for-ni006.html{{/footnote}}
5.2	318
	319
8.1	320	7 January 2022; Alexion, AstraZeneca’s Rare Disease group, has entered into an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody currently in Phase Ib development for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). NI006 specifically targets misfolded transthyretin and is designed to directly address the pathology of ATTR-CM by enabling removal of amyloid fibril deposits in the heart, with the potential to treat patients with advanced ATTR-CM.
5.2	321
	322
	323	Under the agreement, Alexion will be granted an exclusive worldwide licence to develop, manufacture and commercialise NI006.
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8.1	325
5.2	326	ATTR-CM is a systemic, progressive and fatal condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis.1 It remains underdiagnosed and its prevalence is thought to be underestimated due to a lack of disease awareness and the heterogeneity of symptoms.2
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8.1	328
5.2	329	Marc Dunoyer, Chief Executive Officer, Alexion, said: “With 30 years of experience in developing medicines for people with rare diseases, Alexion is uniquely positioned to advance innovative science for small patient populations who are frequently underdiagnosed. The company look forward to applying this expertise to the development of NI006, which is designed to clear cardiac amyloid fibril deposits with the potential to improve cardiac function for patients living with advanced ATTR-CM, who are currently underserved by existing treatment options.”
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8.1	331
5.2	332	There is a significant unmet medical need for patients with various types and levels of severity of amyloidosis that may require multiple mechanisms of action to address those needs. NI006, an ATTR depleter, adds a novel and complementary approach to AstraZeneca and Alexion’s pipeline of investigational therapies focused on amyloidosis and strengthens its broader commitment to addressing cardiomyopathies that can lead to heart failure.
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8.1	335	Financial considerations
	336
5.2	337	Alexion will pay Neurimmune an upfront payment of $30m with the potential for additional contingent milestone payments of up to $730m upon achievement of certain development, regulatory and commercial milestones, as well as low-to-mid teen royalties on net sales of any approved medicine resulting from the collaboration.
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8.1	339
5.2	340	Neurimmune will continue to be responsible for completion of the current Phase Ib clinical trial on behalf of Alexion, and Alexion will pay certain trial costs. Alexion will be responsible for further clinical development, manufacturing and commercialisation.
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	342
8.1	343	= References =
	344
5.2	345	{{putFootnotes/}}

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